How to deal with challenges in the globalization of the pharma industry

Globalization is the interdependence of different pharma manufacturers for their manufacturing activities on one another. The interdependence is not limited by any physical, geographical, or virtual circumstances. It operates and occurs beyond any limits or borders by establishing or coordinating with various pharma facilities worldwide. Apart from many advantages, the pharma community can coordinate to overcome challenges, create innovation, increase market share, and react faster to any global emergency or requirement.

While globalization in the pharma industry is challenging, new techniques and inventions are increasingly bolstering it. Technologies like Digital and Reliable Conservatives enable pharma manufacturers to adopt globalization trends and overcome related challenges conveniently.

Globalization has paved new ways for pharma organizations to deal with market diversification, reduce costs, and innovate their production processes. At the same time, it has also created new challenges for the pharma manufacturers, that require out-of-the-box solutions.

What pharmaceutical areas and/or departments have been influenced by globalization?

As we know, pharma industry comprises many distinct and critical departments, globalization has opened new horizons for each of them. Let's discuss how different departments in the pharma industry have transitioned under the influence of globalization.

R&D  

Research and Development: R&D is an important area of the pharma industry, where an organization continuously works for product improvement and development, in response to various factors such as new product discovery, market complaints & feedback, and increased market share.

Traditionally, firms invested in the R&D in their home countries and/or organizations. They were driven by their own regional requirements, influenced by discreet factors, and targeted their own region. Additionally, their requirements and developmental criterial were easily met in their target area.  However, as technology advanced and people in different parts of the world were more connected, the R&D area also witnessed more opportunities, such as corporation between global corporations, multiples firms, and between firms & research organizations.

As a result, the pharma R&D globalization is benefitting the industry by decreasing the risk of errors in research & failure rate, achieving accurate results. Additionally, technology, knowledge, and expertise sharing, which typically manufacturing organizations lack. This allows the organization to benefit from other organizations rather than funding and developing its own facilities, which often pharma manufacturer lacks, when act in isolation

Manufacturing Globalization

Manufacturing in the pharma industry is responsible for fulfilling market demands by completing all the regulatory, infrastructure, equipment and quality-related requirements. Fulfilling these requirements depends on various factors, and can be limited due to many regional market factors. For example, the unavailability of raw materials can hinder the product manufacturing process, and the inventory issues of a manufacturing machine can decrease the total production hours.

To tackle these problems, pharma organizations globalize their manufacturing operations, where manufacturing requirements can be easily met, and in a cost-effective manner. Globalization offers less disruption, easily arrangement of the required expertise, material, equipment and regulatory compliance.

Globalization also helps to reduce manufacturing costs by strategically selecting the region that offers advantages, such as cheap raw materials, easy maintenance, and availability of spare parts, over others

Supply Chain Globalization

The supply chain is an integral department of the pharma industry, and is responsible to maintain a continuous supply of manufacturing related material, and at the same time is responsible to managing market orders. Globalization has enabled pharma supply chain in reaching beyond their traditional markets. It can open new ways to the competitive markets, when equipped with proper technique and planning.

Another supply chain area where pharma organizations can take advantage of globalization is the sourcing opportunities. They can source their various requirements, such as raw materials, instruments and chemicals, with the most competitive and cost-effective rates. Instead of depending on a single market or sourcing region, globalization enables a pharma organization to diversify its items sourcing and build new partners.

Regulatory regulations

Regulatory regulations are essential to the pharma life cycle, where every pharma product manufacturer is seriously concerned about the regulator's satisfaction. In the traditional market model, every region or market has its own regulatory requirements. The pharma manufacturer is responsible for completing all requirements and gaining approval in advance, if it wants to enter in their markets.

Globalization, however, has changed this scenario with the harmonization of quality policies agreed upon by all major markets. One example is the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), which has become a single source of regulations for pharma drug development worldwide. Irrespective of the region, it helps pharma manufacturers to consult it and prepare themselves when entering the globalization world of the pharma industry.

Challenges in the globalization of the pharma industry

The term globalization is attractive and meaningful to most pharma industries worldwide. However, globalization in the pharma industry is still facing challenges and requires innovative solutions to take maximum benefit from it.

Let's discuss some common challenges in globalization in the pharmaceutical industry, and in the next section, we will try to discuss some ways to overcome

Regulatory Issues

Pharma globalization intends to harmonize the regulatory regulations so that the pharma manufacturers implement compliance requirements that are being enforced and agreed upon worldwide. However, when it comes to pharma manufacturers, regional and/or market-specific regulatory have a significant impact and cannot be denied. It also becomes challenging, because harmonization on a single global regulator challenges the authority of the regional regulator.

Even when a country or market has agreed to the harmonization of regulatory regulations, the role of local enforcement cannot be undermined because drug safety, quality assurance and compliance fulfillment is the responsibility of local authorities, rather than global regulatory harmonization bodies.

Logistics

The pharmaceutical industry requires specialized logistics to transport the final finished product to its end users, especially vaccines and biological products. If not handled properly, the logistics challenge can disrupt the pharma manufacturer and hinder the organization's efforts towards globalization.

During manufacturing, holding and storage, drug specific conditions are fulfilled by the pharma manufacturing organization. However, when it leaves the pharma facility, specialized logistics are required to maintain the drug specific condition, such as temperature and humidity. If not, its therapeutic properties will change and the drug will end up being recalled or discarded.

Arranging logistics for pharma drug manufacturer depends on the area in which the pharma organization is marketing and selling its product.  In resourceful regions or countries, it can be easily arranged. However, countries where their pharma industry has yet to be developed usually face the challenge of the required logistics, and becomes difficult to arrange.

Supply Chain

The pharma supply chain in the globalization, era can be affected because, the product, raw materials, instruments & equipment and various intermediaries pass through different regions or countries that have their laws, such as customs and transportation. Additionally, in conflict-ridden regions it can intensify the supply chain problem.

The supply chain challenges can hamper the manufacturer's ability to deliver on-time and quality products to their end-user

Counterfeit medicines

Counterfeit medicines pose a significant threat to the patient, and at the same time, the manufacturer's reputation & business are also at risk.  Among other reasons for counterfeit medicines, globalization is also seen.

Standardization or regulatory bodies in one working area or region, face difficulties in overseeing the manufacturing facility in other working area, region or market. As a result, it becomes impossible to impose strict control to prevent counterfeiting. 

How to deal with these challenges

Let's discuss some ways we can deal with the challenges faced by pharma globalization.

Meaningful and increased alliances

Globalization involves a variety of stakeholders, rather than only the government. It is beneficial for a pharma manufacturer aiming for globalization to create more meaningful alliances worldwide, especially in the target market.

It enables effective and problem-solving relationships, when required. There can be multiple area of alliances, including, R&D, manufacturing and third-party supply chain integration.

Increased harmonization among regulators

There must be increased harmonization among different regulators in their working regions. The testing protocol of one regulator should be acceptable to another regional regulator, and pharma manufacturers can be allowed to market their products without re-testing and approval if approved by any other regional regulator.

It will enable a pharma manufacturer to quickly adopt globalization without worrying too much about the regulatory approvals on a global level.

Drug safety

Pharma agencies should use the latest techniques and practices to ensure products are safe and have the highest possible quality in their entire life cycle, such as discovery, development, manufacturing, marketing and distribution. Using global approved scientific and personnel expertise, it can help ensuring drug safety in a global approved manner.

Diversification in the supply chain

Disruption in the supply chain can be prevented by diversifying sourcing options rather than only relying on one source. It can be achieved non-conventionally by participating in exhibitions, building relationships with multiple suppliers, and offering business to new suppliers to build confidence

Similarly, disruption in distribution can be prevented by building relationships with logistics that offer pharma-compliant options and use latest technology. It will build good reputation in the market, especially when dealing with critical drug product, such as vaccines and/or biological products

About the Author:

Muhammad Asim Niazi

Muhammad Asim Niazi has a vast experience of about 11 years in a Pharmaceutical company. During his tenure he worked in their different departments and had been part of many initiatives within the company. He now uses his experience and skill to write interested content for audiences at PharmaSources.com.